17-Dimethylaminoethylamino-17-Demethoxygeldanamycin (17-DMAG) in Treating Patients With Metastatic Solid Tumors or Tumors That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00248521|
Recruitment Status : Unknown
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : November 4, 2005
Last Update Posted : August 2, 2013
RATIONALE: Drugs used in chemotherapy, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic solid tumors or tumors that cannot be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: alvespimycin hydrochloride||Phase 1|
- Determine the maximum tolerated dose, dose-limiting toxicity, and recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with unresectable or metastatic solid tumors.
- Determine the feasibility, safety, and toxicity profile of this drug in these patients.
- Determine the clinical pharmacokinetic profile of this drug in these patients.
- Determine tumor response in patients treated with this drug.
- Determine the biologically effective dose.
OUTLINE: This is an open-label, non-randomized, dose-escalation, multicenter study.
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1 hour on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 17-DMAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 10 patients are treated at the MTD.
After completion of study treatment, patients are followed for 28 days.
PROJECTED ACCRUAL: Approximately 25-35 patients will be accrued for this study within 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Masking:||None (Open Label)|
|Official Title:||A Cancer Research UK Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of 17-Dimethylaminoethyl-amino-17-Demethoxygeldanamycin (17-DMAG) Given as a Once Weekly Infusion in Patients With Advanced Solid Tumors|
|Study Start Date :||October 2005|
|Estimated Primary Completion Date :||January 2007|
- Recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) at 28 days after treatment
- Heat shock protein 90 (HSP90) client protein and co-chaperone changes up to 29 days after treatment
- Tumor response by RECIST criteria every 6 weeks while on study
- Clinical pharmacokinetic profile established during the first course of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248521
|Institute of Cancer Research - Sutton|
|Sutton, England, United Kingdom, SM2 5NG|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Belfast City Hospital Trust Incorporating Belvoir Park Hospital|
|Belfast, Northern Ireland, United Kingdom, BT8 8JR|
|Study Chair:||Ian R. Judson, MA, MD, FRCP||Institute of Cancer Research, United Kingdom|